# K253244: AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)

- Pathway: 510(k) (Traditional)
- Applicant: Poskom Co., Ltd.
- Decided: Feb 23, 2026 after 147 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K945707 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143494: ADX6000 Portable X-Ray System; iRayA6, Dexcowin Co., Ltd. (2015) Summary page 6.

## Indications for use
The AirRay-mini is a handheld, portable X-ray generator. This device is intended for use by qualified and trained healthcare professionals on adult patients to produce diagnostic X-ray images of the extremities. This device is not intended for mammography.

Source page: https://510kreport.com/device/K253244
Methodology: https://510kreport.com/methodology
